Real-world evidence (RWE) study of CAR-T agents in leukemia and lymphoma patients.
e19573 Background: Chimeric antigen receptor T (CAR T) cell products are considered gene treatments, producing long term results, with just one infusion. Real world evidence on the two available CAR T cell products, tisagenlecleucel (T) and axicabtagene ciloleucel (AC) are limited in leukemia and lymphoma patients, specifically at the individual product level. This study presents treatment outcomes and resource utilization of these products from a payer perspective. Methods: Patients with evidence of CAR T administration per claims algorithm and from documentation from a prior authorization program from January 1, 2017 to May 30, 2020 were included; the CAR T administration was the index event. Baseline demographics and clinical characteristics, healthcare resource utilization (HCRU) for the CART T administration and pre and post CAR T administration for a fixed 6-month period, and previous treatments were captured and presented by product, using descriptive analytics. Results: The study population included 148 patients, mean age (SD): 57.4 (16.9), with 34% female, and 64% Commercial patients versus 36% Medicare patients, with a mean follow-up of 319 days (SD: 210). There were 15 leukemia patients, 119 lymphoma patients, and 14 patients with other indication in the study population; 71(48%) had evidence of being on a clinical trial during the study. The mean Charleson Comorbidity score at baseline was 3.9. Major comorbidities included anemia (71%), diseases of the heart (72%). 29(20%) patients were treated with T of which 24% were for leukemia and 76% for lymphoma and 67 (46%) were treated with AC of which 100% were for lymphoma, and 52 (35%) patients did not differentiate between products. Majority of the CAR T administration took place inpatient (84%). Baseline 6-month HCRU was 52% ER visits and 59% hospitalizations, compared to post 6-month utilization at 45% ER visits and 49% hospitalizations for the total population. 118 (80%) patients had evidence of prior treatment indicating that the CAR T was at least in the second line setting or higher. The most common priming chemotherapy was cyclophosphamide-fludarabine in 69 (47%) patients. Of the total population, 72% did not have any evidence of further treatment in the available follow-up time, specifically, 47% in the leukemia and 76% in the lymphoma populations, respectively. Conclusions: Majority of patients have evidence of prior treatments before the CAR T index date, indicating relapse. There is evidence of decrease in the HCRU subsequent to treatment, compared to pre period and 72% do not have subsequent treatment in the available follow-up time, indicating a high level of efficacy.